Ambrita Regia

A self-driven professional with 14 years of experience in dealing with Indonesian Authorities and demonstrating strong project management skills. Experienced in regulatory compliance, product licensing, and strategic planning implementation. Capable of working under pressure as an individual and in a team in a fast-paced environment.

Stay at home mom at Self-employed (2023-01 – Present)

• Childcare & Education: Providing continuous supervision, emotional support, and developmental or educational activities. Assisting with homework and managing daily routines like feeding, napping, and bathing.
• Household Management: Planning and preparing nutritious meals, grocery shopping, doing laundry, and maintaining general cleanliness.
• Family Logistics: Scheduling appointments, playdates, school transport, and family activities.
• Financial Administration: Overseeing family budgets, paying bills, and tracking household expenses.

Product Compliance Coordinator at PT. Castrol Indonesia (2013-10 – 2023-04)

• Continuing to liaise with Authorities (MIGAS, Ministry of Industry, Ministry of Trade, BKPM, BSI, etc) to ensure a comprehensive understanding of the renewal process of licenses (Ceisa 4.0, Oil License, SNI Oil License, OSS, NIB, etc, company reports and any updated regulations; proactively engage with the relevant channels to expedite the renewal process.
• A meticulous review of our technical documentation is underway to ensure it aligns with the latest regulatory requirements and standards set by MIGAS.
• Preparing a batch of samples representative of our lubricant products for submission as per MIGAS guidelines; aiming is to demonstrate the quality and compliance of our products, expediting the approval process.
• Providing regular updates to the business regarding the status of the renewal process; encouraging open communication channels for any queries or additional information required.
• Completing all necessary steps well in advance to ensure a timely renewal without disruptions to company operations.

Regulatory Affairs Executive at PT. Nestle Indonesia (2012-07 – 2013-10)

• Product License Registration: Proven track record in successfully navigating and managing product license registrations across diverse sectors.
• Artwork Management: Adept at overseeing and coordinating the artwork management process, ensuring compliance with regulatory standards and brand guidelines.
• 60:40 Trials: Experience in orchestrating 60:40 trials, balancing innovation with regulatory compliance to drive effective product development strategies.
• Product Development: Demonstrated commitment to driving product development initiatives, focusing on quality, market relevance, and adherence to industry standards.
• Proactive Government Relations: Engages proactively with government agencies to establish and maintain positive relationships, ensuring smooth regulatory processes and compliance.

Clinical Research Associate (CRA) II at PT. Parexel International (2008-01 – 2012-03)

• Proven track record in overseeing end-to-end clinical trial processes, ensuring adherence to protocols and timelines.
• Expertise in coordinating multi-disciplinary teams and optimizing resources for successful trial Execution.
• Proficient in the strategic management of clinical materials, ensuring timely availability and compliance with regulatory requirements.
• Experience in implementing efficient logistics and distribution processes for clinical trial supplies.
• Skilled in navigating regulatory landscapes to secure and manage clinical trial licenses.
• Demonstrated success in obtaining necessary approvals and maintaining compliance throughout the trial lifecycle.
• Meticulously conducts document verification processes, guaranteeing accuracy and completeness in accordance with regulatory standards.
• Implements robust quality assurance measures to uphold the integrity of trial-related documentation.
• Breast Cancer Project, TKR project, Asthma Project, Hepatology Project

SWAT Clinical Research Associate Expatriation in Philippine at PT. Parexel International (2010-02 – 2011-01)

• Tuberculosis Projects: Data Cleaning up, Document repositories, and SDV for 100 patients

SWAT Clinical Research Associate in Malaysia and Singapore at PT. Parexel International (2011-02 – 2012-02)

• Breast Cancer Project: Following up the site for patient recruitment, following up for the completed and updated documents
• Ophthalmology Project: Following up the site for patient recruitment, following up for the completed and updated documents

Study Coordinator at Gleneagles CRO Pte, Ltd (2007-06 – 2007-10)

As Study Coordinator in Pulmonology Registry Project, coordinates the clinical research activities in the hospital and implements the strategy of subject recruitment.

• Screening activities by observing hospitalized patient medical records
• Data collection
• Obtaining PI approval for subject randomization
• Going to the subject to perform the study related procedures
• Obtaining subject consent on the Informed Consent Form and their response to the questionnaires which stated on the Case Report Form
• Sending the updated information on the enrollment log
• Submitting the study documents to the ethic committee
• Resolving data queries from Case Report Form that might need clarification.

Quality Operations Officer at PT Pfizer Indonesia (2006-06 – 2007-06)

As a Quality Operations Officer, coordinates with other divisions that involved directly and not directly in the drug production.

Responsibilities in drug production include the inspection of raw material shipment to the factory (amount, price, and quality); performing the inspection of the raw material quality for drug production (drug material and drug packaging material), monitoring drug production process; ensuring product was met the quality requirement either by the laboratory checking and physic examination, ensuring that the quality of the drug were met the requirement when it was packaged and distributed to the market, verifying the consumer's complaint of drug damaged and reporting the drug condition to the Indonesia's FDA or Regulatory Authority (Badan Pengawas Obat dan Makanan / The National Agency of Food and Drug Control).

Pharmacists / Apothecary in Pharmacy – Bandung Institute of Technology (2004-2006)

Bachelor of Pharmacy in Pharmacy – Bandung Institute of Technology (1999-2004)